Protective Efficacy of Plasmodium vivax Radiation-Attenuated Sporozoites in Colombian Volunteers: A Randomized Controlled Trial

PLoS Neglected Tropical Diseases

Volumn 10, Issue 10, 2016, Pages

  Arévalo Herrera, Myriam ^a,b   Vásquez Jiménez, Juan M ^a   Lopez Perez, Mary ^a   Vallejo, Andrés F ^a   Amado Garavito, Andrés B ^a   Céspedes, Nora ^a   Castellanos, Angélica ^a   Molina, Karen ^a   Trejos, Johanna ^c   Oñate, José ^d   Epstein, Judith E ^e   Richie, Thomas L ^f   Herrera, Sócrates ^a,g  

^a Malaria Vaccine and Drug Development Center (MVDC)   (Colombia)

^b UNIVERSIDAD DEL VALLE   (Colombia)

^c Asoclinic Inmunología LTDA ^*  (Colombia)

^d CENTRO MÉDICO IMBANACO   (Colombia)

^e NAVAL MEDICAL RESEARCH CENTER   (United States)

^f SANARIA INC   (United States)

^g Caucaseco Scientific Research Center   (Colombia)

Author keywords

[No Author keywords available]

Indexed keywords

CHLOROQUINE; GAMMA INTERFERON; MALARIA VACCINE; PRIMAQUINE; RADIATION ATTENUATED PLASMODIUM FALCIPARUM SPOROZOITE VACCINE; SPOROZOITE VACCINE; UNCLASSIFIED DRUG; BLOOD GROUP DUFFY SYSTEM; IMMUNOGLOBULIN G; LIVE VACCINE; PROTOZOON ANTIBODY;

ABSENCE OF SIDE EFFECTS; ADULT; ANTIBODY RESPONSE; ARTICLE; BLOOD GROUP DUFFY SYSTEM; CHILL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; FEVER; FOLLOW UP; HEADACHE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNOFLUORESCENCE TEST; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; NONHUMAN; PARASITEMIA; PHASE 2 CLINICAL TRIAL; PLASMODIUM VIVAX MALARIA; POLYMERASE CHAIN REACTION; RADIATION ATTENUATION; RADIATION DOSE; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SPOROZOITE; SWEATING; YOUNG ADULT; ADOLESCENT; ADVERSE EFFECTS; ANIMAL; ANOPHELES; BLOOD; CLINICAL TRIAL; COLOMBIA; ETHNOLOGY; IMMUNIZATION; IMMUNOLOGY; INSECT BITE; MALARIA, VIVAX; MIDDLE AGED; PARASITOLOGY; PHYSIOLOGY; PLASMODIUM VIVAX; PROCEDURES; RADIATION RESPONSE; VOLUNTEER;

ADOLESCENT; ADULT; ANIMALS; ANOPHELES; ANTIBODIES, PROTOZOAN; COLOMBIA; DUFFY BLOOD-GROUP SYSTEM; FEMALE; HUMANS; IMMUNIZATION; IMMUNOGLOBULIN G; INSECT BITES AND STINGS; MALARIA VACCINES; MALARIA, VIVAX; MALE; MIDDLE AGED; PLASMODIUM VIVAX; SINGLE-BLIND METHOD; SPOROZOITES; VACCINES, ATTENUATED; VOLUNTEERS; YOUNG ADULT;

EID: 84994223674     PISSN: 19352727     EISSN: 19352735     Source Type: Journal    
DOI: 10.1371/journal.pntd.0005070     Document Type: Article

References (32)

1. World Health OrganizationWorld Malaria Report 2015. Geneva, Switzerland: World Health Organization, 2015.
2. World Health Organization. Immunization, vaccines and biologicals SAGE Meeting of October 2015: World Healt Organization; 2015 [October 26, 2015]. Available from: http://www.who.int/immunization/sage/meetings/2015/october/en/.
3. Clyde DF, Most H, McCarthy VC, Vanderberg JP, Immunization of man against sporozite-induced falciparum malaria. Am J Med Sci. 1973;266(3):169–77. 4583408
4. Rieckmann KH, Carson PE, Beaudoin RL, Cassells JS, Sell KW, Letter: Sporozoite induced immunity in man against an Ethiopian strain of Plasmodium falciparum. Trans R Soc Trop Med Hyg. 1974;68(3):258–9. 4608063
5. Clyde DF, Immunization of man against falciparum and vivax malaria by use of attenuated sporozoites. Am J Trop Med Hyg. 1975;24(3):397–401. 808142
6. Doolan DL, Hoffman SL, The complexity of protective immunity against liver-stage malaria. J Immunol. 2000;165(3):1453–62. 10903750
7. Richie TL, Billingsley PF, Sim BK, James ER, Chakravarty S, Epstein JE, et al. Progress with Plasmodium falciparum sporozoite (PfSPZ)-based malaria vaccines. Vaccine. 2015;33(52):7452–61. doi: 10.1016/j.vaccine.2015.09.09626469720
8. Clyde DF, McCarthy VC, Miller RM, Hornick RB, Specificity of protection of man immunized against sporozoite-induced falciparum malaria. Am J Med Sci. 1973;266(6):398–403. 4590095
9. Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, Doolan DL, et al. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis. 2002;185(8):1155–64. doi: 10.1086/33940911930326
10. Wong KA, Zhou A, Rodriguez A, Protective immunity induced by daily bites from irradiated mosquitoes infected with Plasmodium yoelii. Parasite Immunol. 2008;30(9):482–6. doi: 10.1111/j.1365-3024.2008.01046.x18761489
11. Longley RJ, Hill AV, Spencer AJ, Malaria vaccines: identifying Plasmodium falciparum liver-stage targets. Front Microbiol. 2015;6:965. doi: 10.3389/fmicb.2015.0096526441899
12. Clyde DF, Immunity to falciparum and vivax malaria induced by irradiated sporozoites: a review of the University of Maryland studies, 1971–75. Bull World Health Organ. 1990;68Suppl:9–12. 2094597
13. Salas ML, Romero JF, Solarte Y, Olano V, Herrera MA, Herrera S, Development of sporogonic cycle of Plasmodium vivax in experimentally infected Anopheles albimanus mosquitoes. Mem Inst Oswaldo Cruz. 1994;89Suppl 2:115–9. 7565121
14. Solarte Y, Manzano MR, Rocha L, Hurtado H, James MA, Arevalo-Herrera M, et al. Plasmodium vivax sporozoite production in Anopheles albimanus mosquitoes for vaccine clinical trials. Am J Trop Med Hyg. 2011;84(2 Suppl):28–34. doi: 10.4269/ajtmh.2011.09-049921292875
15. Herrera S, Fernandez O, Manzano MR, Murrain B, Vergara J, Blanco P, et al. Successful sporozoite challenge model in human volunteers with Plasmodium vivax strain derived from human donors. Am J Trop Med Hyg. 2009;81(5):740–6. doi: 10.4269/ajtmh.2009.09-019419861603
16. Herrera S, Solarte Y, Jordan-Villegas A, Echavarria JF, Rocha L, Palacios R, et al. Consistent safety and infectivity in sporozoite challenge model of Plasmodium vivax in malaria-naive human volunteers. Am J Trop Med Hyg. 2011;84(2 Suppl):4–11. doi: 10.4269/ajtmh.2011.09-049821292872
17. Arevalo-Herrera M, Forero-Pena DA, Rubiano K, Gomez-Hincapie J, Martinez NL, Lopez-Perez M, et al. Plasmodium vivax sporozoite challenge in malaria-naive and semi-immune Colombian volunteers. PLoS One. 2014;9(6):e99754. doi: 10.1371/journal.pone.009975424963662
18. International Conference on Harmonisation. ICH Harmonised Tripartite Guideline- Guideline for Good Clinical Practice E6 (R1): International Conference on Harmonisation; 1996 June 1996.
19. Hurtado S, Salas ML, Romero JF, Zapata JC, Ortiz H, Arevalo-Herrera M, et al. Regular production of infective sporozoites of Plasmodium falciparum and P. vivax in laboratory-bred Anopheles albimanus. Ann Trop Med Parasitol. 1997;91(1):49–60. 9093429
20. Jordan-Villegas A, Perdomo AB, Epstein JE, Lopez J, Castellanos A, Manzano MR, et al. Immune responses and protection of Aotus monkeys immunized with irradiated Plasmodium vivax sporozoites. Am J Trop Med Hyg. 2011;84(2 Suppl):43–50. doi: 10.4269/ajtmh.2011.09-075921292877
21. Zuluaga-Idarraga L, Yepes-Jimenez N, Lopez-Cordoba C, Blair-Trujillo S, Validation of a method for the simultaneous quantification of chloroquine, desethylchloroquine and primaquine in plasma by HPLC-DAD. J Pharm Biomed Anal. 2014;95:200–6. doi: 10.1016/j.jpba.2014.03.00624682018
22. U.S. Food and Drug AdministrationGuidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Washington D.C., United States of America: U.S. Food and Drug Administration; 2007.
23. Cespedes N, Arevalo-Herrera M, Felger I, Reed S, Kajava AV, Corradin G, et al. Antigenicity and immunogenicity of a novel chimeric peptide antigen based on the P. vivax circumsporozoite protein. Vaccine. 2013;31(42):4923–30. doi: 10.1016/j.vaccine.2013.05.08223954378
24. Valderrama-Aguirre A, Quintero G, Gomez A, Castellanos A, Perez Y, Mendez F, et al. Antigenicity, immunogenicity, and protective efficacy of Plasmodium vivax MSP1 PV200l: a potential malaria vaccine subunit. Am J Trop Med Hyg. 2005;73(5 Suppl):16–24. 16291762
25. Vallejo AF, Rubiano K, Amado A, Krystosik AR, Herrera S, Arevalo-Herrera M, Optimization of a Membrane Feeding Assay for Plasmodium vivax Infection in Anopheles albimanus. PLoS Negl Trop Dis. 2016;10(6):e0004807. doi: 10.1371/journal.pntd.000480727355210
26. Aguiar JC, Bolton J, Wanga J, Sacci JB, Iriko H, Mazeika JK, et al. Discovery of Novel Plasmodium falciparum Pre-Erythrocytic Antigens for Vaccine Development. PLoS One. 2015;10(8):e0136109. doi: 10.1371/journal.pone.013610926292257
27. Menard D, Barnadas C, Bouchier C, Henry-Halldin C, Gray LR, Ratsimbasoa A, et al. Plasmodium vivax clinical malaria is commonly observed in Duffy-negative Malagasy people. Proc Natl Acad Sci U S A. 2010;107(13):5967–71. doi: 10.1073/pnas.091249610720231434
28. Ngassa Mbenda HG, Das A, Molecular evidence of Plasmodium vivax mono and mixed malaria parasite infections in Duffy-negative native Cameroonians. PLoS One. 2014;9(8):e103262. doi: 10.1371/journal.pone.010326225084090
29. Giefing-Kroll C, Berger P, Lepperdinger G, Grubeck-Loebenstein B, How sex and age affect immune responses, susceptibility to infections, and response to vaccination. Aging Cell. 2015;14(3):309–21. doi: 10.1111/acel.1232625720438
30. Ndungu FM, Bull PC, Ross A, Lowe BS, Kabiru E, Marsh K, Naturally acquired immunoglobulin (Ig)G subclass antibodies to crude asexual Plasmodium falciparum lysates: evidence for association with protection for IgG1 and disease for IgG2. Parasite Immunol. 2002;24(2):77–82. 11874562
31. Cutts JC, Powell R, Agius PA, Beeson JG, Simpson JA, Fowkes FJ, Immunological markers of Plasmodium vivax exposure and immunity: a systematic review and meta-analysis. BMC Med. 2014;12:150. doi: 10.1186/s12916-014-0150-125199532
32. Mellouk S, Lunel F, Sedegah M, Beaudoin RL, Druilhe P, Protection against malaria induced by irradiated sporozoites. Lancet. 1990;335(8691):721. 1969073